BIOGLAS MICROCARRIER BEAD
FDA 510(k) clearance K852506 · decided 1985-07-12
Clearance details
- K-number
- K852506
- Device name
- BIOGLAS MICROCARRIER BEAD
- Applicant
- Solohill Engineering, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-12
- Decision date
- 1985-07-12
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- KJB
- Device class
- 1
- Regulation number
- 864.2240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CELL-CULTURE SHAKER (K881466) | Cryodyne Technologies, Inc. | 1988-04-18 |
| CORNING DISPOSABLE ROLLER BOTTLES (K872076) | Corning Medical & Scientific | 1987-06-15 |
Recalls involving this device
No recalls on record reference this clearance.